CTBS Tissue Banking Regulations & Standards 2

Question 1

Under FDA 21 CFR Part 1271, which of the following is classified as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P)?

Accepted Answer

Corneal tissue for transplantation

Answer

Corneal tissue is an HCT/P regulated under 21 CFR Part 1271, whereas whole blood, vascularized organs, and secreted products fall under different regulatory frameworks.

Question 2

What is the primary purpose of the AATB Standards for Tissue Banking?

Accepted Answer

To establish voluntary accreditation benchmarks that exceed federal minimums

Answer

AATB Standards serve as voluntary accreditation criteria that typically exceed FDA regulatory minimums to promote best practices in tissue banking.

Question 3

Which FDA regulation specifically addresses the registration and listing requirements for tissue establishments?

Accepted Answer

21 CFR Part 1271 Subpart B

Answer

21 CFR Part 1271 Subpart B covers registration and listing requirements for HCT/P establishments with the FDA.

Question 4

A tissue bank discovers a potential infectious disease transmission from an allograft. Under FDA regulations, this must be reported as a:

Accepted Answer

Biological Product Deviation Report (BPDR)

Answer

Biological Product Deviation Reports (BPDRs) are required under 21 CFR 1271.350 when an HCT/P may have caused or contributed to serious adverse reactions.

Question 5

The AATB accreditation cycle for tissue banks requires re-inspection every:

Accepted Answer

3 years

Answer

AATB requires accredited tissue banks to undergo re-inspection every three years to maintain their accreditation status.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Tissue Banking Regulations & Standards 2